Actively Recruiting
Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)
Led by aTyr Pharma, Inc. · Updated on 2025-05-07
25
Participants Needed
15
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a 2-Part study with Part A, a double-blind, randomized, placebo-controlled, PoC study to evaluate the efficacy, safety, and tolerability of efzofitimod in patients with SSc-ILD. The primary objective of the study is to evaluate the PoC for efficacy in a population with SSc-ILD. While improvement of ILD is the outcome of interest, the study will also evaluate changes in the skin. After initial screening (up to 4 weeks), approximately 25 eligible participants will be randomized 2:2:1 to 1 of 2 active (experimental) dose arms or placebo, administered every 4 weeks up to and including Week 20. Part B is an optional open-label extension to Part A in which participants can receive 450 mg efzofitimod every 4 weeks for 6 doses.
CONDITIONS
Official Title
Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of systemic sclerosis based on 2013 ACR/EULAR criteria
- Duration of systemic sclerosis less than 84 months from first non-Raynaud symptom
- HRCT scan within 3 months showing SSc-related interstitial lung disease with over 10% lung involvement
- Clinical presentation consistent with limited or diffuse cutaneous systemic sclerosis
- Receiving mycophenolate mofetil (MMF) at 2 gm/day or equivalent for at least 3 months, or stable dose of alternate immunosuppressant for 4 weeks prior to baseline
You will not qualify if you...
- Pulmonary disease with forced vital capacity (FVC) less than or equal to 45% predicted or DLco less than or equal to 30% predicted; FEV1/FVC ratio less than 0.7
- Pulmonary artery hypertension on parenteral therapy or signs of right heart failure
- HRCT scan within 3 months showing other confounding lung pathology
- Treatment with corticosteroids over 10 mg/day prednisone or equivalent within 2 weeks before Day 1
- Treatment with more than one immunosuppressant such as MMF, methotrexate, azathioprine, or leflunomide
- Treatment in past 12 months with rituximab, intravenous immune globulin, tocilizumab, cyclophosphamide, pirfenidone, or tyrosine-kinase inhibitors
- Other rheumatic autoimmune diseases besides systemic sclerosis
- Active heavy smoking of tobacco or nicotine products
- History or presence of anti-synthetase syndrome or Jo-1 antibody positive at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
aTyr Investigative Site
Los Angeles, California, United States, 90024
Actively Recruiting
2
aTyr Investigative Site
San Diego, California, United States, 92093
Actively Recruiting
3
aTyr Investigative Site
Miami, Florida, United States, 33146
Actively Recruiting
4
aTyr Investigative Site
Chicago, Illinois, United States, 60153
Actively Recruiting
5
aTyr Investigative Site
Chicago, Illinois, United States, 60611
Actively Recruiting
6
aTyr Investigative Site
Chicago, Illinois, United States, 60612
Actively Recruiting
7
aTyr Investigative Site
New Orleans, Louisiana, United States, 70115
Actively Recruiting
8
aTyr Investigative Site
New York, New York, United States, 10027
Actively Recruiting
9
aTyr Investigative Site
Cleveland, Ohio, United States, 44195
Actively Recruiting
10
aTyr Investigative Site
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
11
aTyr Investigative Site
Charleston, South Carolina, United States, 29425
Actively Recruiting
12
aTyr Investigative Site
Dallas, Texas, United States, 75204
Actively Recruiting
13
aTyr Investigative Site
Houston, Texas, United States, 77204
Actively Recruiting
14
aTyr Investigative Site
Salt Lake City, Utah, United States, 84112
Actively Recruiting
15
aTyr Investigative Site
Richmond, Virginia, United States, 23284
Actively Recruiting
Research Team
A
aTyr Pharma Clinical Research
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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